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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, nephrostomy
510(k) Number K024050
Device Name COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact DEBBIE SCHMITT
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact DEBBIE SCHMITT
Classification Product Code
LJE  
Date Received12/09/2002
Decision Date 02/27/2003
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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